Clinical Trials Advisor

Clinical trial sites across the world may come under more scrutiny if Congress approves the FDA’s fiscal 2011 budget proposal.

Using Bayesian statistical methods in clinical trials could save device sponsors time and money, according to a new final guidance.

The FDA warned Cayman Chemical for sponsoring and investigating a clinical trial of an eyelash-growth enhancement drug without filing an investigational new drug (IND) application or getting IRB approval.

The UK’s National Institute for Health and Clinical Excellence (NICE) Appraisal Committee has recommended against paying for three cancer drugs, citing insufficient clinical evidence of benefits to support the high costs of the products.

Investigators will need to be more diligent in reporting their financial interests now that the FDA is stepping up its efforts to verify financial disclosures during site inspections.

Sponsors conducting dose-ranging studies of diabetes mellitus treatments should include a washout period for previously treated subjects and show at least neutral effects on cardiovascular (CV) risk factors, the European Medicines Agency (EMEA) advises in a new draft guideline.

Sponsors developing products to treat osteoarthritis should use pain attributable to the target joint as the primary endpoint in clinical trials, the European Medicines Agency (EMEA) says.

Industry says two draft guidances on computer-assisted detection (CADe) devices may be burdensome or unnecessary, echoing comments made at a workshop last fall that urged the FDA to redraft the guidances.

Samya Nasr, an investigator in several clinical cystic fibrosis (CF) trials, received a warning letter for informed consent failures and violations of protocol.

East Carolina University’s IRB has resolved concerns HHS’ Office for Human Research Protections (OHRP) had with its approval and waivers of informed consent documents.

Although Intermountain Health Care has adequately addressed several concerns raised by HHS’ Office for Human Research Protections (OHRP), it should revise several policies and procedures involving its IRB, a determination letter says.

Howard University will implement a training program in April to address concerns raised by HHS’ Office for Human Research Protections (OHRP) following a complaint alleging inappropriate conduct by a research assistant.